Wound healing and dermal regeneration in severe burn patients treated with NovoSorb® Biodegradable Temporising Matrix: a prospective clinical study

Mr Cheng Hean Lo1, Mr Jason Brown2, Dr Eric Dantzer3, Mr Peter Maitz4, Mr John Vandervord5, Mr Marcus Wagstaff6, Dr Timothy Barker7, Ms Heather  Cleland1

1Victorian Adult Burns Service, Melbourne, Australia, 2Professor Stuart Pegg Adult Burns Centre, Royal Brisbane and Women’s Hospital , Herston, Australia, 3Centre des Brûlés, Hôpital d’Instruction des Armées Sainte-Anne , , France, 4Burns Unit, Concord Repatriation General Hospital, Concord, Australia, 5Department of Burns, Reconstructive and Plastic Surgery, Royal North Shore Hospital, St. Leonards, Australia , 6Adult Burns Service and Department of Plastic and Reconstructive Surgery, Royal Adelaide Hospital, Adelaide, Australia, 7PolyNovo Biomaterials Pty Ltd, Port Melbourne, Australia

Abstract:

Introduction
For extensive burn injuries, there may be insufficient autologous donor skin for early debridement and grafting in a single stage. A novel, synthetic polyurethane dermal template (NovoSorb® Biodegradable Temporising Matrix, BTM) was developed to address this need. The aim of this study was to evaluate use of BTM for primary dermal repair after deep burn injury.

Methods
This sponsored prospective, non-controlled, open label, multi-centre study involved the use of BTM for treatment of individuals with burn injuries requiring excision and skin grafting (Australian and New Zealand Clinical Trials Registry [ANZCTR] Identifier: ACTRN 12615000405516). This clinical study was conducted from September 2015 to May 2018 involving major adult burn centres in Australia and France. The primary endpoint was % split skin graft take over applied BTM at 7–10 days after grafting. Secondary endpoints included % BTM take, incidence of infection and adverse events, and scar quality to 12 months after BTM application.

Results
Thirty patients were treated with BTM and delayed split skin grafting. The % graft take had a mean of 81.9% and % BTM take had a mean of 88.6%, demonstrating effective integration of BTM. When managed appropriately, it was possible for BTM to integrate successfully despite findings suggestive of infection. Scar quality improved over time.

Discussion
These results provide additional clinical evidence on the safety and performance of BTM as an effective dermal substitute in the treatment of patients with deep burn injuries.


Biography:

Cheng Hean Lo is a plastic and reconstructive surgeon and specialist burn surgeon at the Victorian Adult Burns Service in Melbourne, Victoria. He completed a clinical research fellowship in 2013-2015 and since then a Master of Philosophy in the field of cultured epithelial autografts. His areas of interest and expertise include skin tissue engineering and clinical trials.

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